Sleep assessment device - ARTG 206199
Access comprehensive regulatory information for Sleep assessment device in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 206199 and sponsored by Excellcare Pty Ltd, manufactured by Itamar Medical Ltd in Israel. The device registration started on February 18, 2013.
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To be used as a diagnostic tool in the medical management of sleep-related breathing disorders. Can be used in the diagnosis of myocardial ischemia and endothelium dysfunctions. To be worn on the wrist by the patient at home while they sleep along with a non-invasive finger mounted pneu-optical probe to measure the peripheral arterial tonometry (PAT) signal. In addition to the PAT signal, oxygen saturation, actigraphy (body movement), pulse rate, body position and snoring (dB) are also recorded and stored on the device from which the recorded signals can be downloaded to a computer for automatic analysis and reporting utilising proprietary algorithams. Can provide analysis of respiratory disturbance, apnea-hypopnea, endothelia function, oxygen desaturation, REM/NREM sleep stages, light/deep sleep stages, sleep/wake states, heart rate, oxygen saturation level, body position and snoring.